NuDEL Delivery System - General aorta endovascular stent-graft
Access comprehensive regulatory information for NuDEL Delivery System - General aorta endovascular stent-graft in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Intervene Medical Pty Ltd, manufactured by Numed Inc in United States of America. The device registration started on May 31, 2017.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The NuMED NuDEL Delivery System is recommended for stent implantation in the native and/or recurrent Coarctation of the Aorta with the following conditions: • Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging • Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function • Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated • Stenosis diameter < 20% of the adjacent vessel diameter. Stenosis that would present increased risk of vascular damage of disruption; or aneurysm associated with Coarctation of the aorta Right Ventricular Outflow Tract (RVOT) Indicated for treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement.